REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers (RESPPECT Trial)
RESPPECT
2 other identifiers
interventional
21
1 country
1
Brief Summary
This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedStudy Start
First participant enrolled
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2021
CompletedDecember 12, 2023
December 1, 2023
2.4 years
February 26, 2019
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Change in score of Stroke Knowledge Questionnaire
2.1.1 We will measure participant retention of in-hospital stroke education using a Stroke Knowledge Questionnaire. The questionnaire consists of 17 items. Scores range from 1-17. The questionnaire is based on the American Heart Association Stroke Knowledge Questionnaire. The questionnaire is administered during incident hospitalization for stroke (baseline score) and repeated at the 1 month post discharge appointment. The baseline score is subtracted from the 1 month appointment score and the result reflects improvement or worsening performance. The two groups are compared with respect to this difference between baseline pre-stroke education score (number correct) and 1 month post discharge score. Greater positive difference between pre-test and 1 month test reflect improved performance.
30 days
Change in hospital readmission rate
2.1.2 We will measure the hospital readmission rate at 30 days and compare readmission rates between the two groups of usual education and enhanced education. Lower readmission rates is considered optimal.
30 days
Change in score of Stroke Knowledge Questionnaire
2.1.1 We will measure participant retention of in-hospital stroke education using a Stroke Knowledge Questionnaire. The questionnaire consists of 17 items. Scores range from 1-17. The questionnaire is based on the American Heart Association Stroke Knowledge Questionnaire. The questionnaire is administered during the incident hospitalization for stroke (baseline score) and repeated at the 6 month post discharge appointment. The baseline score is subtracted from the 6 month appointment score and the result reflects improvement or worsening performance. The two groups are compared with respect to this difference between baseline pre-stroke education score (number correct) and 6 month post discharge score. Greater positive difference between pre-test and 6 month test reflect improved performance.
180 days
Change in hospital readmission rate
We will measure the readmission rate at 180 days and compare readmission rates between the two groups of usual education and enhanced education. Lower readmission rates is considered optimal.
180 days
Secondary Outcomes (12)
Change in Brief Health Literacy Screen
30 days
Change in systolic blood pressure
30 days
Change in Modified Rankin Score
30 days
Change in Barthel Index
30 days
Change in Brief Health Literacy Screen
180 days
- +7 more secondary outcomes
Study Arms (2)
Enhanced Stroke Education
OTHERThis group of participants will receive enhanced education provided by the Stroke Coordinator at the time of discharge. The enhanced education session will last 30 minutes with the participant.
Usual Stroke Education
OTHERThis group of participants will receive the usual stroke education provided by the usual Neuroscience Registered Nurse throughout the hospitalization and at the time of discharge.
Interventions
In addition to the general stroke education materials and verbal education, the enhanced stroke education group will receive a personalized verbal and written information addressing the patient's specific risk factors including their current status and goals, laboratory values and goals, and current blood pressure and goal. Specific stroke type and etiology is discussed, medication including indication, dose, frequency, physical activity goals, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, and education over the importance of keeping follow up appointments including Stroke Clinic. Verbal feedback of key points is encouraged.
The usual stroke education group will receive general stroke education including written and verbal information about signs and symptoms of stroke, best practice to engage medical treatment if stroke occurs, general information about heart healthy diet and need for daily physical activity as well as need for compliance with medication recommendations. The education is incorporated with routine patient care and as allowed during quiet times. On the day of discharge, the patient will receive written materials reviewing stroke symptoms, risk factors, heart healthy diet and follow up appointments. The patient will receive written and verbal information about medications including indication, dose, frequency, physical activity goal, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, the importance of keeping follow up appointments including Stroke Clinic.
Eligibility Criteria
You may qualify if:
- patients hospitalized with primary diagnosis of acute or subacute ischemic cerebral infarction
- years of age or older
- English speaking
- admitted to hospital Sunday through Thursday
- patient or responsible primary caregiver able to understand and provide informed consent
- prognosis for survival greater than 6 months
- one or more vascular risk factors (HTN, DLP, current smoker, DM, obesity)
- live in NWA area (Benton, Boone, Carroll, Madison, and Washington counties),
- have a working phone.
You may not qualify if:
- admitted with transient ischemic attack
- admitted with an intracerebral hemorrhage
- experience an in-hospital ischemic cerebral infarction
- hospital to hospital transfer patients
- nursing home as primary residence before or after discharge
- hospice
- inability to comply with post discharge follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington Regional Medical Center
Fayetteville, Arkansas, 72703, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Tremwel, MD
Washington Regional Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- The who Advanced Practice Registered Nurse performing the outpatient follow up visits at one and six months will remain blinded to the enrollment of each participant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stroke Program Medical Director
Study Record Dates
First Submitted
February 26, 2019
First Posted
March 4, 2019
Study Start
May 6, 2019
Primary Completion
September 14, 2021
Study Completion
September 14, 2021
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share